Sterile Latex Surgical Gloves Powder Free

K212596 · Amazing Rubber Products Pvt, Ltd. · KGO · Mar 1, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K212596
• Device Name: Sterile Latex Surgical Gloves Powder Free
• Applicant: Amazing Rubber Products Pvt, Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 1, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, disposable natural rubber latex surgical gloves; worn by operating room personnel to protect surgical wounds from contamination. Device provides physical barrier between clinician and patient. Manufactured per ASTM D3577-2019. Sterilized via Gamma and ETO methods to SAL 10^-6. Packaged to maintain sterility for 5-year shelf life. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified against ASTM D3577-2019 (physical properties), ASTM D5151-2019 (pinholes), ASTM D6124-06 (powder residue), ASTM D5712-15 (protein content), and ISO 10993 series (biocompatibility: irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity).

Technological Characteristics

Material: Natural rubber latex (Type I). Dimensions: Length 484-488mm, thickness 0.16-0.33mm. Sterilization: Gamma and ETO (SAL 10^-6). Standards: ASTM D3577-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-15, ISO 10993-5/10/11, USP <85>/<151>. No software or connectivity.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. No specific age or gender restrictions.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• JR Medic Latex Surgeon's Gloves Sterile Powder Free (K192328)

Submission Summary (Full Text)

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March 1, 2022

Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K212596

Trade/Device Name: Sterile Latex Surgical Gloves Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: January 19, 2022 Received: January 19, 2022

Dear Manoj Zacharias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212596

Device Name

Sterile Latex Surgical Gloves Powder Free

#### Indications for Use (Describe)

A Sterile Latex Surgical Cloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510K SUMMARY K212596 As required by: 21CFR § 807.92

#### A. APPLICANT INFORMATION

| 1. | Submitter Name | Amazing Rubber Products Pvt. Ltd. |
|----|----------------|-------------------------------------------------------------------------------------------|
| 2 | Date Submitted | 14 January 2021 |
| 3 | Address | Plot No 14c, Cochin Special Economic Zone ,<br>Kakkanad, Cochin-682 037,<br>Kerala- India |
| 4 | Phone | 9447053062 |
| 5 | Fax | ----- |
| 6 | E-mail | [e-mail] |
| 7 | Contact Person | Jayasankar S |
| 8 | Designation | Executive Director |
| 9 | Contact Number | 9447053062 |
| 10 | Contact Email | [e-mail] |

### B. US AGENT & CONTACT PERSON INFORMATION

| 11 | US agent &<br>contact person name | Manoj Zacharias |
|----|-----------------------------------|----------------------------------------------------------------------------------|
| 12 | Address | Liberty Management Group Ltd.<br>75 Executive Dr. STE 114 Aurora, IL-60504, USA. |
| 13 | Phone | [phone] |
| 14 | Fax | [phone] |
| 15 | E-mail | [e-mail] |

#### C. DEVICE IDENTIFICATION

| 16 | Common Name | Surgical Gloves |
|----|--------------------------------------|-------------------------------------------|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| | Product proprietary or<br>trade name | Amazing+ |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Review Panel | Gen & Plastic Surgery |

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#### D. PREDICATE DEVICE INFORMATION

| Description | Name of device | 510k<br>Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>device | JR Medic Latex Surgeon's Gloves<br>Sterile Powder Free with protein<br>content labeling claim of 50 µg/<br>dm² or less per glove of<br>extractable protein | K192328 | JR Engineering & Medical<br>Technologies (M) SDN.<br>BHD.<br>Lot 8 &10, Jalan Zurah 3<br>& Lot 1&3, Jalan Zurah<br>3A/1, Pusat Perindustrian<br>2, 44200 Rasa, Hulu<br>Selangor, Selangor Darul<br>Ehsan, Malaysia. |

#### E. DESCRIPTION OF THE DEVICE

The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves.

The classification is: Type I - gloves compounded primarily from natural rubber latex.

The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.

All variants share the same natural color (No Color is added).

The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.

#### F. INDICATION FOR USE:

A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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# G. TECHNOLOGICAL CHARACTERISTICS COMPARISON

## a. General Characteristics Comparison

| Characteristic | Subject device<br>K212596 | Predicate device<br>K192328 | Comparison | Characteristics | Acceptance criteria of the standard | | Comparison |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Product Code | KGO | KGO | Same | | Subject device<br>K212596 | Predicate device<br>K192328 | |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | Dimensions<br>Length:- Min<br>265 mm | 486 mm | 300 mm | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Class | 1 | 1 | Same | Size<br>6.0 (76+/-6mm)<br>6.5 (83+/-6mm)<br>7.0 (89+/-6mm)<br>7.5 (95+/-6mm)<br>8.0 (102+/6mm)<br>8.5 (108+/6mm)<br>9.0 (114+/6mm) | 80mm<br>87mm<br>91mm<br>97mm<br>103mm<br>110mm<br>116mm | 78mm<br>85mm<br>88mm<br>97mm<br>103mm<br>110mm<br>116mm | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Intended Use | A Sterile Latex Surgical Gloves Powder Free is a<br>device made of natural<br>rubber intended to be worn<br>by operating room personnel<br>to protect a surgical wound<br>from contamination. | A latex surgeon's glove is a<br>device made of natural<br>rubber intended to be worn<br>by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | Similar | Cuff, Palm,<br>Finger Tip Min<br>0.10 mm | Cuff-<br>0.16mm<br>Palm-0.21mm<br>Finger Tip-<br>0.33mm | Cuff-<br>0.11mm<br>Palm-0.18mm<br>Finger Tip-<br>0.21mm | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Powdered or Powder<br>free | Powder free | Powder free | Same | Tensile Strength<br>24Mpa minimum | 28.61Mpa | 26.00Mpa | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Material | Natural Rubber | Natural Rubber | Same | Ultimate<br>Elongation<br>750% minimum | 871% | 860% | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Classification as per<br>ASTMD3577-09,<br>Standard Specification<br>for Rubber Surgical<br>Gloves | Type I - gloves<br>compounded primarily<br>from natural rubber latex | Type I - gloves<br>compounded primarily<br>from natural rubber latex | Same | Stress at 500%<br>5.5 MPa Max | 5.1Mpa | 2.7 Mpa | |
| Sterilization | ETO/as well as Radiation,<br>SAL- 10-6 | ETO/as well as Radiation,<br>SAL- 10-6 | Similar | Tensile Strength<br>18Mpa minimum | 24.12Mpa | 22.0Mpa | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for Rubber<br>Surgical Gloves |
| Label and Labeling | Meet FDA's label<br>Requirements | Meet FDA's label<br>Requirements | Same | Ultimate<br>Elongation<br> | 732% | 725% | |
| Special label claim | Protein content labeling<br>claim of 50µg/dm² or less per<br>glove of extractable protein<br>for Latex Surgeon's Gloves<br>Powder Free. | Protein content labeling<br>claim of 50µg/dm² or less<br>per glove of extractable<br>protein for Latex Surgeon's<br>Gloves Powder Free. | Same | | | | |
| Type of use | Over the counter use | Over the counter use | Same | | | | |

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## b. Technological Characteristics Comparison

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| Characteristics | Acceptance criteria of the standard | Predicate device<br>K192328 | Subject device<br>K212596 | Comparison |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Freedom from<br>Holes<br>AQL 1.5 | AQL 1.0 | AQL 1.0 | | Similar<br>Meets ASTM D3577-2019 and<br>ASTM D5151-2019, Standard Test<br>Method for Detection of Holes in<br>Medical Gloves |
| Powder residue<br>for powder free<br>glove Powder<br>content < 2<br>mg/Glove | 0.38 mg/Glove | 0.34 mg/Glove | | Similar<br>Meets ASTM D3577-2019 and ASTM<br>D6124-06,( Reapproved 2017),<br>Standard Test Method for Residual<br>Powder on Medical Gloves |
| Protein Content<br>< 50 µg/ dm² | 46.40µg/ dm² | 43µg/ dm² | | Similar<br>Meets ASTM D3577-2019, ASTM<br>D5712(15), Standard Test Method for<br>the Analysis of Aqueous Extractable<br>Protein in Natural Rubber and Its<br>Products Using the Modified Lowry<br>Method |
| Characteristics | Acceptance criteria of the standard | | | Comparison |
| | Biocompatibility | Subject device<br>K212596 | Predicate device<br>K192328 | |
| Skin Irritation &<br>Skin Sensitization | ISO 10993-10,Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization | Non- irritant and<br>Non-Sensitizer | Non- irritant and<br>Non-Sensitizer | Same |
| In vitro<br>cytotoxicity | ISO 10993-<br>5:2009(E),Biological<br>Evaluation of Medical<br>Devices - Part 5-Tests<br>for in vitro Cytotoxicity | cytotoxic | cytotoxic | Same |
| Material Mediated<br>pyrogenicity | ISO 10993-11:2017(E)<br>,Biological Evaluation of<br>Medical Devices - Part<br>11, Tests for Systemic<br>Toxicity and USP 41<br><151>Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| Systemic Toxicity | ISO 10993-11:2017(E)<br>,Biological Evaluation of<br>Medical Devices - Part<br>11, Tests for Systemic<br>Toxicity | Under the<br>conditions<br>of study the<br>device extracts do<br>not pose a<br>systemic toxicity<br>concern | No data available | ---- |
| Bacterial<br>Endotoxin | USP 42 < 85> | <20EU/pair of<br>gloves | No data available | ---- |

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There is no difference with predicate device.

## H. SUMMARY OF NONCLINICAL PERFORMANCE DATA

Bench tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards and table below:

ASTM D3577-2019:- Standard Specification for Rubber Surgical Gloves.

ASTM D5151-2019:- Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.

ASTM D5712-15:- Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.

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ASTM F1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization.

ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity

ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests

USP 41 <151> Pyrogen Test

ISO 11137-1-2006/ (R) 2010 - validation of sterilization process

ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose

USP 42 <85> Bacterial Endotoxin Test

| Test<br>Methodology/Standard | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| ISO 10993-10<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done<br>for irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under the condition<br>of study not an<br>irritant | Under the<br>conditionof<br>study not an<br>irritant |
| ISO 10993-10<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done<br>Skin sensitization. | To<br>determine<br>the<br>skin<br>sensitization potential of the<br>material both in terms<br>of<br>induction<br>and elicitation in Guinea<br>Pig. | Under the conditions<br>of the study not a<br>sensitizer | Under the<br>conditionsof<br>the study not a<br>sensitizer |
| ISO 10993-5:2009<br>biological evaluation of<br>medical devices - part 5,<br>tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner andouter<br>surface) Extracts in L-929<br>mouse fibroblasts<br>cells using elution method. | Under the conditions<br>of study non<br>cytotoxic | Under the<br>conditionsof<br>the study<br>cytotoxic. |
| USP 42 <85> | Bacterial EndotoxinTest | <20EU/pair of<br>gloves | <20EU/<br>pair of<br>gloves |

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| Test<br>Methodology/Standard | Purpose | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| ISO 10993-11:2017<br>biological evaluation of<br>medical devices - part 11,<br>tests for systemic toxicity. | To determine the acute systemic<br>toxicity potential of the test<br>item extracts (both inside and<br>outersurfaces) in Swiss<br>Albino mice. | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the<br>conditions<br>of study the<br>device extracts<br>do not pose a<br>systemic<br>toxicity concern |

#### PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-2019, STANDARD SPECIFICATION FOR RUBBER SURGICAL GLOVES SIZES AVAILABLE: - 6, 6'/2, 7, 7'/2, 8, 8'/2, 9

| Sl.No | Criteria | Specification as per<br>ASTM D3577-2019,<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Average value of<br>subject device | Whether subject<br>device complied<br>with the ASTMD<br>3577-2019,<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves |
|-------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 1 | Length | | | |
| | Size 6 | Min 265mm | 484mm | Yes |
| | Size 6'/2 | Min 265mm | 485mm | Yes |
| | Size 7 | Min 265mm | 486mm | Yes |
| | Size 7'/2 | Min 265mm | 486mm | Yes |
| | Size 8 | Min 265mm | 487mm | Yes |
| | Size 8'/2 | Min 265mm | 487mm | Yes |
| | Size 9 | Min 265mm | 488mm | Yes |
| 2 | Width | | | |
| | Size 6 | 76+/-6mm | 80mm | Yes |
| | Size 6'/2 | 83+/-6mm | 87mm | Yes |
| | Size 7 | 89+/-6mm | 91mm | Yes |
| | Size 7'/2 | 95+/-6mm | 97mm | Yes |
| | Size 8 | 102+/-6mm | 103mm | Yes |
| | Size 8'/2 | 108+/-6mm | 110mm | Yes |
| | Size 9 | 114+/-6mm | 116mm | Yes |
| 3 | Finger Thickness<br>(All sizes) | Min 0.10mm | 0.33mm | Yes |
| 4 | Palm Thickness<br>(All sizes) | Min 0.10mm | 0.21mm | Yes |
| 5 | Cuff Thickness<br>(All sizes) | Min 0.10mm | 0.16mm | Yes |
| SL.NO | CRITERIA | Specification as per<br>ASTMD3577-2019<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Average Value<br>of Subject<br>Device | Whether Subject Device<br>Complied with the<br>ASTMD3577-2019<br>Standard Specification<br>for Rubber Surgical<br>Gloves |
| 6 | Tensile Strength | | | |
| | Before aging<br>(All sizes) | 24Mpa minimum | 28.61Mpa | Yes |
| | After aging@<br>70°±2C for 166±2 hr<br>(All sizes) | 18Mpa minimum | 24.12Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging<br>(All sizes) | 750% minimum | 871% | Yes |
| | After aging@<br>70°±2C for 166±2 hr<br>(All sizes) | 560% minimum | 732% | Yes |
| 8 | Stress at 500%<br>before ageing<br>(All sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| 9 | Pinhole AQL | | | |
| | Before aging<br>(All sizes) | Max 1.5 | 1.0 | Yes |
| | After aging@<br>70°C for 7 days<br>(All sizes) | Max 1.5 | 1.0 | Yes |

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#### SUMMARY OF CLINICAL PERFORMANCE DATA

Clinical data was not required for this submission.

## CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Sterile Latex Surgical Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K192328, JR MEDIC Latex Surgeon's Gloves Sterile Powder Free.